目的 通过运用证据图系统检索并梳理近6年中药注射液治疗慢性阻塞性肺疾病(简称慢阻肺)的临床研究,了解中药注射液治疗慢阻肺的研究现状和研究质量.方法 通过检索PubMed、Embase、Cochrane Li-brary、Web of Science、中国知网(CNKI)、万方数据库(Wanfang)、中文科技期刊数据库(VIP)和中国生物医学文献服务系统(SinoMed)数据库里中药注射液治疗慢阻肺的相关文献,检索日期为2017年1月至2022年11月.采用图表结合文字的方式呈现并分析证据分布特征.最终纳入136篇临床研究文献,包括128篇干预性研究和8篇观察性研究.结果 对纳入文献进行分析,共获得27种中药注射液,以痰热清注射液的使用频次最高,用药存在未经辨证论治或超说明书使用的情况.近年来发文量呈下降趋势,以单中心、小样本、短周期的临床试验居多,合并用药和结局指标种类较多,且文献质量普遍不高.结论 需进一步规范临床用药与结局指标评定,充分发掘中医优势,提高随机对照试验研究的方法学质量,以便形成更多的高质量证据,为中药注射液治疗慢阻肺的有效性和安全性提供依据,促进中医药事业的发展.
Evidence Map Analysis of Clinical Studies on the Prevention and Treatment of COPD with Traditional Chinese Medicine Injection in the Past Six Years
Objective:To use the evidence map system to search and sort out the clinical studies on the preven-tion and treatment of chronic obstructive pulmonary disease(COPD)by traditional Chinese medicine(TCM)injec-tion in the past six years,and to understand the distribution of evidence and the quality of studies in this field.Methods:The literature on the treatment of COPD with TCM injection in PubMed,Embase,Cochrane Library,Web of Science,CNKI,Wanfang,VIP,and China Biomedical Literature Service System(SinoMed)databases was searched from January 2017 to November 2022.Charts and texts were used to present and analyze the distribution of evidence.A total of 136 clinical studies were included,including 128 interventional studies and 8 observational studies.Results:A total of 27 kinds of TCM injections were obtained,with Tanreqing injection having the highest frequency,and there were situations where the drug was used without syndrome differentiation or off-label use.In recent years,the number of publications has shown a downward trend,mainly single-center,small-sample,short-term clinical trials,and there were many types of combined drugs and outcome indicators,and the quality of litera-ture was generally not high.Conclusion:In the future,it is necessary to further standardize clinical medication and outcome index evaluation,fully explore the advantages of TCM,and improve the methodological quality of ran-domized controlled trial studies,so as to form more high-quality evidence.
Chronic obstructive pulmonary diseaseTraditional Chinese medicine injectionClinical studiesEvi-dence maps